Uses of Acetaminophen and Codeine Tablets:

• It is used to ease pain.

What do I need to tell my doctor BEFORE I take Acetaminophen and Codeine Tablets?

• If you have an allergy to acetaminophen, codeine, or any other part of this medicine (acetaminophen and codeine tablets).
• If you are allergic to this medicine (acetaminophen and codeine tablets); any part of this medicine (acetaminophen and codeine tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you have been told by your doctor that you are a rapid metabolizer of some drugs.
• If you are breast-feeding. Do not breast-feed while you take this medicine (acetaminophen and codeine tablets).

This is not a list of all drugs or health problems that interact with this medicine (acetaminophen and codeine tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (acetaminophen and codeine tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Acetaminophen and Codeine Tablets?

• Tell all of your health care providers that you take this medicine (acetaminophen and codeine tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (acetaminophen and codeine tablets) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• You will be watched closely to make sure you do not misuse, abuse, or become addicted to this medicine (acetaminophen and codeine tablets).
• Allergic reactions have happened with this medicine (acetaminophen and codeine tablets). Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
• Avoid taking other products that have acetaminophen in them. Check labels closely. Too much acetaminophen may cause liver problems.
• Follow the directions exactly. Do not take more acetaminophen in a day than directed. If you do not know how much acetaminophen you can take in a day, ask your doctor or pharmacist. Some people may take up to 4,000 mg (milligrams) in a day if told to do so by the doctor. Some people (like people with liver problems and children) should take less acetaminophen. Call your doctor right away if you have taken too much acetaminophen in a day, even if you feel well.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (acetaminophen and codeine tablets).
• Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men).
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this medicine (acetaminophen and codeine tablets).
• Taking an opioid drug like this medicine (acetaminophen and codeine tablets) may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
• If you are 65 or older, use this medicine (acetaminophen and codeine tablets) with care. You could have more side effects.
• The chance of very bad side effects may be higher in children. This may be more likely to happen in children who have breathing problems. Deadly breathing problems have happened with the use of codeine in some children. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine (acetaminophen and codeine tablets), call your doctor right away.

How is this medicine (Acetaminophen and Codeine Tablets) best taken?

Use this medicine (acetaminophen and codeine tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Do not take this medicine (acetaminophen and codeine tablets) with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• If you have been taking this medicine (acetaminophen and codeine tablets) for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine (acetaminophen and codeine tablets) stops working well. Do not take more than ordered.
• Long-term or regular use of opioid drugs like this medicine (acetaminophen and codeine tablets) may lead to dependence. Lowering the dose or stopping this medicine (acetaminophen and codeine tablets) all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your doctor before you lower the dose or stop this medicine (acetaminophen and codeine tablets). You will need to follow your doctor’s instructions. Tell your doctor if you have more pain, mood changes, thoughts of suicide, or any other bad effects.

What do I do if I miss a dose?

• If you take this medicine (acetaminophen and codeine tablets) on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine (acetaminophen and codeine tablets) is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Feeling confused.
• Severe constipation or stomach pain. These may be signs of a severe bowel problem.
• Not able to pass urine or change in how much urine is passed.
• Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak.
• Mood changes.
• Noisy breathing.
• Change in eyesight.
• Seizures.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• A severe and sometimes deadly problem called serotonin syndrome may happen if you take this medicine (acetaminophen and codeine tablets) with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.

What are some other side effects of Acetaminophen and Codeine Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Constipation.
• Stomach pain.
• Upset stomach or throwing up.
• Dry mouth.
• Sweating a lot.
• Headache.
• Flushing.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Acetaminophen and Codeine Tablets?

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Store this medicine (acetaminophen and codeine tablets) in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep this medicine (acetaminophen and codeine tablets) safe. Keep all drugs away from pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (acetaminophen and codeine tablets) is refilled. If you have any questions about this medicine (acetaminophen and codeine tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.